Lilly QA Representative - Materials Management in Concord, North Carolina
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our 35,000 employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.
Lilly is entering an exciting period of growth and we are committed to delivering innovative medicines to patients around the world. Lilly is investing over $1 billion to create a new state-of-the-art manufacturing site, in Concord, North Carolina. The brand-new facility will utilize the latest technology to increase the company's manufacturing capacity in parenteral (injectable) medications, device assembly and packaging operations. This is an exciting once-in-a-lifetime opportunity to help build and operate a new site. The Lilly Concord site will be built using the latest high-tech equipment, advanced highly integrated and automated manufacturing systems, and have a focus on minimizing the impact to our environment. This is an opportunity you don’t want to miss!
The Quality Assurance Representative is responsible for demonstrating leadership, teamwork, and quality and regulatory knowledge and oversight to provide guidance, consultation and influence in the design, verification, and startup of the manufacturing areas at Lilly’s new Concord, North Carolina site. The QA position is essential for ensuring GMP compliance in the design, delivery, verification, qualification, and start up to ensure regulatory approval of the facility. The Quality Assurance Representative for Materials Management is responsible for the site materials management systems. The Quality Assurance Representative provides Quality Oversight for the set-up and management of suppliers and materials in quality management systems such as (SAP, Trackwise, Veeva). The QA Representative will be responsible for review and release of incoming materials utilized by the site. The QA Representative will also act as the QA data steward for creation, maintenance, and oversight of quality master data in SAP.
Work with site staff and global resources to establish site material suppliers
Coordinates the appropriate tasks to develop and maintain the approved supplier list
Conduct material and supplier risk assessments and periodic reviews of supplier performance
Coordinate and write Supplier, Service Provider, and Affiliate Quality Agreements, including networking with site resources to ensure compliance to associated requirements
Provide input, guidance and recommendation for Supplier/Service Providerapproval and certification activities
Perform and/or oversee materials SAP data steward functions
Create and manage quality master data in SAP including Q-info records for materials
Provides support to the warehouse for incoming receipt, sampling and testing
Maintain complaint database (track supplier responses for warehouse, incomingand operations complaints)
Lead, mentor, and coach site personnel on the material management process
Provide input and guidance to site activities (e.g., six sigma, new product/processdevelopment, change controls) as material quality SME
Review and Redline Materials and other GMP documents, includingspecifications and procedures. Provide procedure ownership and subject matter expertise, as necessary.
Provide the voice of quality to the Material Management Governance Committee and Supplier Certification Global Committee, providing input and support as needed in order to ensure compliance
Support regulatory inspection activities as needed by providing documentation and SME support
Track and report materials management metrics to Supplier Relationship Meetings, supplier committees, and Materials Management Governance Committee
Lead, as required, local or global teams, committees, or other groups to resolve quality issues and ensure site compliance to Lilly Standards and external regulations
- Bachelor's degree in a science, engineering, computer, or pharmaceutical related field of study or equivalent industry experience
Experience working in the pharmaceutical or medical device industry in QA roles
Previous materials management and supplier management experience
Proficiency with material management computer systems and applicationsincluding Microsoft Office products, SAP, Veeva QDocs and TrackWise or similar systems
Previous regulatory inspection readiness and inspection execution experience
Strong oral and written communication and interpersonal skills
Ability to influence externally with suppliers and resources across sites
Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate and Site Goals
Strong technical aptitude and ability to work with component and technical stewards
Previous facility or area start up experience
Previous experience with device, parenteral and laboratory materials
Previous experience as power user or data steward for SAP or other inventory management systems
Previous experience with deviation and change management systems including Trackwise
Previous technical writing experience
Technical aptitude and ability to train and mentor others
Ability to work 8-hour days – Monday through Friday
Ability to travel up to 10% to Indianapolis, IN for meetings and coordination with global regulatory organizations.
Ability to work overtime as required
Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( LillyRecruitingCompliance@lists.lilly.com ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response.
Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.
Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women’s Network, Working and Living with Disabilities. Learn more about all of our groups.
As a condition of employment with Eli Lilly and Company and its subsidiaries in the United States and Puerto Rico, you must be fully COVID-19 vaccinated and provide proof of vaccination satisfactory to the company (subject to applicable law).